Validation & Product QA

We are looking for a MEDICAL Validation & Product QA to join our team!

Location: Netanya

BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer.

The opportunity:

In this role, you will manage and oversee overall validation activities and ensure compliance with quality and regulatory requirements while supporting the organization’s goals.

This position reports directly to the QA/RA Director, reflecting its critical role in maintaining and enhancing quality standards.

In this position you will be asked to:

• Establish and review design V&V, excel files validation, and process validation protocols in accordance with standards and regulation requirements
• Evaluate processes and equipment to ensure regulatory and quality compliance.
• Review validation plans, test results, and summary reports for regulatory compliance
• Provide guidance on quality/regulatory requirements for validation activities, including production, manufacturing, user requirements specifications, and testing strategies.
• Offer cross-departmental support to ensure adherence to ISO13485, FDA requirements, and other applicable quality, validation guidance and regulations, including performing standards gap assessments.
• Understands validation/technical problems and evaluates their potential impact on product quality
• Evaluate potential impact of validations as part of change control process
• Provide quality assurance monitoring of projects to assure regulatory compliance of validation and design processes,
• Maintain the device risk management file
• Maintain Traceability matrices
• Participate in cross-functional teams to define validation strategies and objectives that support organizational needs.
• Participate in projects as a design team member to ensure proper selection of new equipment in support of validation.

A successful candidate will have the following qualifications:

• 4-7 years of experience within a medical device company
• Strong knowledge of medical device standards and background in qualification documentation review
• B.Sc. Engineer in Biomedical/Biotechnology – an advantage
• Experience in data analysis – an advantage
• Strong technical and engineering knowledge - – an advantage
• Excellent written and verbal communication skills in both Hebrew and English
• A team player with strong communication and collaboration skills

BioProtect is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.